MATERIAL ADDITION LEXAN & K-RESIN

MATERIAL ADDITION LEXAN & K-RESIN is an FDA 510(k)-cleared medical device (K833554) manufactured by Procedure Products, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 1984. Regulation: 8.